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COMPLETED Phase 1

H5N1 (Clade 2) Vaccination of Adults and Elderly

NCT00680069 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this research study is to study the safety and effectiveness of vaccinating individuals who have previously received an avian influenza vaccine derived from one type of H5N1 virus with a vaccine derived from a different type of avian influenza virus. A second reason for this study is to compare responses in people who have received two different but similar types of H5N1 vaccine to the responses in subjects who receive 2 doses of only the H5N1 vaccine used in this study. The information obtained may provide important information into the usefulness of a pre-pandemic vaccination. Participants will include 600 healthy adult volunteers, ages 19 and older, in the United States. Study procedures include: physical exams, vaccination with either a low dose (15 micrograms) or high dose (90 micrograms) of vaccine, blood samples, and maintaining a memory aid to record oral temperatures and side effects. Study participation will be approximately 7 months.

Conditions Studied

Interventions

  • BIOLOGICAL Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005

Study Locations (8)

California

  • Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases — Stanford

Iowa

  • University of Iowa - Vaccine Research and Education Unit — Iowa City

Maryland

  • University of Maryland School of Medicine - Center for Vaccine Development - Baltimore — Baltimore

Missouri

  • Saint Louis University - Center for Vaccine Development — St Louis

North Carolina

  • Duke Translational Medicine Institute - Clinical Vaccine Unit — Durham

Ohio

  • Cincinnati Children's Hospital Medical Center - Infectious Diseases — Cincinnati

Tennessee

  • Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center — Nashville

Texas

  • Baylor College of Medicine - Molecular Virology and Microbiology — Houston

Trial Details

FieldValue
Enrollment Target 517 participants
Start Date 2008-11
Est. Completion 2009-11
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00680069

The ClinicalTrials.gov registry entry for NCT00680069 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 517 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention — of which Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00680069 reports 8 study locations spanning 8 distinct geographic areas — top geographies include California, Iowa, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00680069 about?

NCT00680069 is a clinical study titled "H5N1 (Clade 2) Vaccination of Adults and Elderly". The purpose of this research study is to study the safety and effectiveness of vaccinating individuals who have previously received an avian influenza vaccine derived from one type of H5N1 virus with a vaccine derived from a different type of avian influenza virus. A second reason for this study is ...

What is the current status of trial NCT00680069?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 517 participants. The study started on 2008-11. Estimated completion is 2009-11.

What conditions does trial NCT00680069 study?

This clinical trial studies the following conditions: Influenza. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00680069?

The interventions under investigation include: Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00680069?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00680069 being conducted?

This trial has 8 study locations across California, Iowa, Maryland, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial